Device recall
Z-0081-2019: BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos…
FDA device recall · Class III · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-0081-2019 |
|---|---|
| Recall event | 81097 |
| Product | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma… |
| Product code | MNM |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 25, 2019 |
| PMA numbers | P950009 |
| FEI number | 1119779 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database